White Matter Hyperintensities Burden in Adult Patients With Cyanotic Congenital Heart Disease: a Pilot Study

NCT03487302 | Completed

• 1 other identifier: LEUCO
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims at investigating the role of cyanotic congenital heart disease (cCHD) on brain aging. The investigators assume that due to congenital and acquired cardiovascular abnormalities, cCHD patients could show radiologic (and clinical) signs of precocious brain aging and eventual cognitive decline.

Conditions

Aging, Premature; Congenital Heart Disease; White Matter Hyperintensities

Outcome Measures

Primary Outcomes (1)

• White matter hyperintensities volume expressed in mm^3

  Semi-automated quantification performed through ITK-SNAP

  3 years

Study Arms (2)

cCHD

Other: Brain MRI; Other: Neuropsychological test battery

CONTROLS

Other: Brain MRI

Interventions

Brain MRI OTHER

Acquisition of 3D T1-weighted, 3D FLAIR and GRE brain MRI scans

CONTROLS; cCHD

Neuropsychological test battery OTHER

1. Mini Mental State Examination (MMSE), Measso et al. (1993); 2. Frontal Assessment Battery (FAB), Appollonio et al. (2005); 3. Symbol Digit Test, Amodio et al. (2002); 4. Digit Cancellation Test, Della Sala et al. (1992); 5. Trial Making Test (TMT A-B), Giovagnoli et al. (1996); 6. Weigl's Sorting Test, Laicona et al. (2000) and Inzaghi (2010); 7. Digit Span, Orsini et al (1987); 8. Corsi block-tapping test, Orsini et al. (1987); 9. Babcock story recall test, Carlesimo et al. (2002); 10. Phonemic verbal fluency in MDB, Caltagirone and Carlesimo (2010); 11. Semantic verbal fluency, Novelli (1986); 12. Imitating gestures, De Renzi et al. (1980); 13. Coloured Progressive Matrices (CPM47), Measso et al. (1993).

cCHD

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* for the patient group, being an adult subject affected with cyanotic congenital heart disease, whether surgically corrected or not; * for the control group, being an healthy subject.

You may qualify if:

• for the patient group, being an adult subject affected with cyanotic congenital heart disease, whether surgically corrected or not.
• for the control group, being an healthy subject.

You may not qualify if:

• any contraindication to magnetic resonance imaging;
• any pathological condition and/or symptomp that could alter the white matter hyperintensities burden, among which:
• inflammatory, infectious, demyelinating or dysmyelinating diseases of the CNS;
• ischemic, haemorrhagic or traumatic brain events and eventual gliotic and malacic or lacunar sequelae;
• genetic diseases (whether mendelian or mitochondrial) of the CNS;
• cerebral amyloid angiopathy;
• CADASIL;
• cerebral arteriovenous malformations;
• primary or metastatic brain neoplasms which cause neurological symptoms and/or brain parenchymal sequelae from surgical excision;
• patent oval foramen;
• being pregnant;
• migraine with aura (Bashir, Lipton, Ashina, \& Ashina, 2013).

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milano, 20097, Italy

Location

Related Publications (1)

• Yushkevich PA, Piven J, Hazlett HC, Smith RG, Ho S, Gee JC, Gerig G. User-guided 3D active contour segmentation of anatomical structures: significantly improved efficiency and reliability. Neuroimage. 2006 Jul 1;31(3):1116-28. doi: 10.1016/j.neuroimage.2006.01.015. Epub 2006 Mar 20.

  PMID: 16545965 BACKGROUND

MeSH Terms

Conditions

Aging, Premature; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Francesco Sardanelli, MD

  IRCCS Policlinico S. Donato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 4, 2018
• Study Start: October 17, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)